The World Health Organization (WHO) denied inspecting Maiden Pharmaceuticals or assessing any of its products. "The stated manufacturer is authorised and regulated by the State Drugs Controller, Haryana, India. This manufacturer has not been inspected nor any of its products assessed in any way by the WHO," the global health body said on Tuesday.
The company, meanwhile, claims on its website that it "efforts of practicing and providing high-quality products are recognized by National & International certifying agencies and have honored us with ISO 9001:2000 and WHO GMP certificate."
recently came under the scanners after four of its cough syrups were linked to over 60 deaths among children in Gambia, West Africa. These products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
'Products positive for diethylene glycol and ethylene Glycol'
In its reply to CNBC-TV18 on Tuesday, the WHO said samples of medicines used by children in Gambia "came back positive for contaminants diethylene glycol and ethylene Glycol".
As per the WHO, some toxic effects of diethylene glycol and ethylene glycol can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury.
The WHO noted that 72 percent of the cases of acute kidney injuries were found in children below 2 years of age. The products concerned are paracetamol, promethazine, and cough syrup. The country began recalling the products on October 2, 2022
Cause of the contamination
It said the cause of the contamination of these products is still under investigation. It, however, added that the point of contamination may have been at the point of manufacture.
"Failure to observe Good Manufacturing Practices (GMP) may be a contributory factor," the WHO said. "Previous cases of diethylene glycol/ethylene glycol contamination have been due to manufacturer errors, including or poor practice at the manufacturing facility," it said.